# Vascular Solutions, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 116 (2000–2024): 115 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Vascular Solutions, Inc. (104); Vascular Solutions, LLC (11); Vascular Solutions (1)
- Product codes: DQY (27), QSX (18), GEX (13), QEZ (13), DQO (12), DQX (11), KRD (5), DXC (3), DYB (3), FMF (2), MAV (2), MGB (1)
- 510(k) review time since 2016: median 86 days, against 113 for FDA's reviews in the same codes and years (16 of 28 faster)
- Predicates its devices cite: 183 (103 its own); citations of its devices by later devices: 168 (103 its own)
- Recalls linked to its devices: 25 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Asahi Intecc Co., Ltd.: 5 (https://510kreport.com/company/asahi-intecc)
- Diomed, Inc.: 5 (https://510kreport.com/company/diomed)
- Spectranetics Corp.: 5 (https://510kreport.com/company/spectranetics)
- Velocimed, Inc.: 3 (https://510kreport.com/company/velocimed)
- Biosphere Medical, S.A.: 3 (https://510kreport.com/company/biosphere-medical)
- Mallinckrodt Medical: 3 (https://510kreport.com/company/mallinckrodt-medical)
- Merit Medical Systems, Inc.: 2 (https://510kreport.com/company/merit-medical-systems)
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)

## Firms that cite its devices most
- Lumen Biomedical, Inc.: 4 (https://510kreport.com/company/lumen-biomedical)
- Imds Operations B.V.: 3 (https://510kreport.com/company/imds-operations)
- Possis Medical, Inc.: 3 (https://510kreport.com/company/possis-medical)
- Control Medical Technology: 3 (https://510kreport.com/company/control-medical-technology)
- Reflow Medical, Inc.: 3 (https://510kreport.com/company/reflow-medical)
- Cook, Inc.: 3 (https://510kreport.com/company/cook)
- Invatec Innovative Technologies, S.R.L.: 2 (https://510kreport.com/company/invatec-innovative-technologies)
- Sciton, Inc: 2 (https://510kreport.com/company/sciton)

## Its most-cited devices
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage (2003), cited by 8
- K063371: Pronto V3 Extraction Catheter, Model 5003 (2006), cited by 8
- K032763: Vascular Solutions Pronto Extraction Catheter (2003), cited by 8
- K060327: Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter (2006), cited by 7
- K082337: Minnie Support Catheter (2009), cited by 5
- K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter, (2009), cited by 4

## Recent decisions
- K233729: Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 (May 31, 2024)
- K230637: Wattson temporary pacing guidewire (2250) (May 5, 2023)
- K220647: GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) (Aug 18, 2022)
- K221470: Langston dual lumen catheter (Jun 17, 2022)
- K212211: Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter (Feb 9, 2022)
- K212167: R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire (Feb 9, 2022)
- K210647: SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter (Apr 30, 2021)
- K193119: Twin-Pass Dual Access Catheter (Jun 29, 2020)

Source page: https://510kreport.com/company/vascular-solutions